clobetasol propionate

Product NDC: 21695-201
11-digit product format: 216950201
Labeler code: 21695
Product ID: 21695-201_df79a35c-ce5c-452e-b81e-50a014fc94f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Rebel Distributors Corp
Application: ANDA074392
Marketing category: ANDA
Marketing start: 1996-09-30
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-201		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-201	21695-201-15	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-201	21695-201-60	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-201-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-201-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-201-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-201-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-201-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-201-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-201-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-201-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-201-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-201-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-201-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-201-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-201-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-201-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-201-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-201-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-201-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-201-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-201-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-201-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-201-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-201-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-201-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-201-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-201-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-201-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-201-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-201-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-201-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-201-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-201-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-201-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-201-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-201-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-201-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-201-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-201-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-201-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-201-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-201-15	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074392-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		1996-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074392-001	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074392-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074392-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074392-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074392-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074392-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074392-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074392-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074392-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074392-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074392-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074392-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074392-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074392-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074392-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074392-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074392-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074392-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074392-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074392-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074392-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074392-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074392-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074392-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074392-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074392-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074392-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074392-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074392-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074392-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074392-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074392-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074392-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074392-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074392-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074392-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074392-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074392-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074392-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074392-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074392-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074392-001	AB1	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20abe2c3-3e80-d2b2-39eb-3156e4af4799	Product name	3	20250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6f	Product name	1	20250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571df	Product name	7	20250107
3813b789-94b9-edd6-f010-6b926dd462e5	Product name	5	20230113
30eee8a1-850e-41ed-b5ab-761301aeab49	Product name	6	20221206
18e5b6f7-c414-b1f1-b684-17fdd02c215e	Product name	4	20210927
1c87bbde-dd91-a122-db33-67ae814cb645	Product name	7	20210510
519b5875-7d7d-4aa6-9d3d-470fa1376595	Product name	4	20200227
98669154-3e9c-47da-8a2c-656ab71848be	Product name	2	20180607
8d4f8539-436f-453b-8b76-5322d403fc8e	Product name	1	20180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5	Product name	2	20171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-201-15	2019-09-24	C162847	48780-1	934fe258-49e3-48b1-e053-8cdaa90a720a	CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)
21695-201-60	2019-09-24	C162847	48780-1	934fe258-49e3-48b1-e053-8cdaa90a720a	CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-201-15	clobetasol propionate	15 g in 1 TUBE	CREAM	15		1
21695-201-60	clobetasol propionate	60 g in 1 TUBE	CREAM	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-201-15	GM - Gram	21695-201	d1a7a3af-5047-460f-a00a-8d28c2c681ac	1	2012-07-24
21695-201-60	GM - Gram	21695-201	6549fab7-6f63-4395-980b-aa96746f0bd5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
clobetasol propionate	ACTIVE INGREDIENT	779619577M	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
clobetasol	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
anhydrous trisodium citrate	INACTIVE INGREDIENT	RS7A450LGA	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
chlorocresol	INACTIVE INGREDIENT	36W53O7109	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
polyoxyl 100 stearate	INACTIVE INGREDIENT	YD01N1999R	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1
white wax	INACTIVE INGREDIENT	7G1J5DA97F	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-201	CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101123_df79a35c-ce5c-452e-b81e-50a014fc94f4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2d4fa3a3-dc1c-4d3c-9959-4751e09d25be	2025-07-08	Adverse reactions	Exact identifier application applno (ANDA): 074392 application number: ANDA074392
Clobetasol Propionate	CLOBETASOL PROPIONATE	Proficient Rx LP	e0f7bc85-9c13-44df-9b37-c216ecfe3ffe	2024-03-01	Adverse reactions	Exact identifier application applno (ANDA): 074392 application number: ANDA074392

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
779619577M	CLOBETASOL PROPIONATE	25122-46-7	CLOBETASOL PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861495	clobetasol propionate 0.05 % Topical Cream	PSN	df79a35c-ce5c-452e-b81e-50a014fc94f4	1
861448	clobetasol propionate 0.05 % Topical Ointment	PSN	df79a35c-ce5c-452e-b81e-50a014fc94f4	1
861448	clobetasol propionate 0.0005 MG/MG Topical Ointment	SCD	df79a35c-ce5c-452e-b81e-50a014fc94f4	1
861495	clobetasol propionate 0.5 MG/ML Topical Cream	SCD	df79a35c-ce5c-452e-b81e-50a014fc94f4	1
861495	clobetasol propionate 0.05 % Topical Cream	SY	df79a35c-ce5c-452e-b81e-50a014fc94f4	1
861448	clobetasol propionate 0.05 % Topical Ointment	SY	df79a35c-ce5c-452e-b81e-50a014fc94f4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-201-15	21695020115	15 g in 1 TUBE	15 g	Historical
21695-201-60	21695020160	60 g in 1 TUBE	60 g	Historical